.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201675

« Back to Dashboard
NDA 201675 describes ESTRADIOL, which is a drug marketed by Mayne Pharma, Mylan, Lannett Holdings Inc, Ortho Mcneil Pharm, Amneal Pharms, Mylan Technologies, Epic Pharma Inc, Barr Labs Inc, Usl Pharma, Breckenridge Pharm, Teva Pharms Usa, Barr, Watson Labs, Luitpold, Sandoz, and Watson Labs Inc, and is included in twenty-one NDAs. It is available from thirty suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.

Summary for NDA: 201675

Tradename:
ESTRADIOL
Applicant:
Mylan Technologies
Ingredient:
estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 201675

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 201675

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 201675 ANDA Mylan Pharmaceuticals Inc. 0378-4640 0378-4640-26 8 POUCH in 1 CARTON (0378-4640-26) > 1 PATCH in 1 POUCH (0378-4640-16) > 3.5 d in 1 PATCH
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 201675 ANDA Mylan Pharmaceuticals Inc. 0378-4641 0378-4641-26 8 POUCH in 1 CARTON (0378-4641-26) > 1 PATCH in 1 POUCH (0378-4641-16) > 3.5 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.025MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc